Operator

J&J Family of CompaniesGlobal Clinical Development Operations (GCDO) Late Development Trial Leader, Associate Director in
Titusville, New Jersey

Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Global Clinical Development Operations (GCDO) Late Development Trial Leader (LD GTL) located in Spring House, USA; Titusville, USA; Beerse, Belgium; High Wycombe, UK Leiden, South Holland; or Breda, Netherlands .

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. We pursue the most promising science, wherever it might be found.

The GCDO Late Development Trial Leader (LD GTL) has primary global accountability at the trial level within the GCDO organization. The GTL is accountable and provides operational expertise for the successful cross-functional delivery of assigned global clinical trial(s), within agreed timelines and budget, and in alignment with all the applicable SOPs and regulatory requirements.

The incumbent is accountable for oversight of external service providers (ESP), including ESP contracts and budgets. In addition, he/she will be involved in planning and execution of both internally managed and outsourced trials, with scope from draft protocol elements document to availability of the Clinical Study Report and applicable disclosure of the trial results.

The GTL is responsible for leading the cross-functional Trial Team (including GCDO and non-GCDO members) and collaborates with all trial team members, building the trial operational plan, in alignment with the organizational and the Therapeutic Area (TA) Clinical Team’s objectives. The GTL defines risk mitigation strategies and ensures implementation thereof.

The GTL maintains oversight of the trial by taking an operational leadership role in a matrix organization; this includes coordinating activities in the Trial Team and ensuring ad-hoc trial Working Groups are organized as needed, driving issue identification and resolution, contingency planning, and decision-making.

Identifies risks and ensures mitigation and contingencies are being initiated and followed through (including management of CAPAs).

You are responsible for overall trial budget and contract management, including updates for scope changes, review & approval of external service provider (ESP) contracts, change orders and ensures services are delivered.

You are responsible to drive the final study placement, and ensure alignment with and communication to the involved partners, including TA and regional TA experts

Develop the trial ESP strategy for the assigned trial in line with the overall program ESP strategy.

You are responsible for CRO management, including initiation of selection process, SOW development, budget and change orders and oversight of all deliverables outsourced to the CRO.

You possess a Bachelor’s or higher degree, preferably in Life Sciences (e.g., Biology, Chemistry, Nursing, and Pharmacy)

You have 8 or more year’s clinical trial work experience in the pharmaceutical/ medical device industry and/or CRO.

Strong knowledge in Late Development clinical trials is highly preferred. An exploratory scientific mindset with focus on disease area and PK/PD/biomarkers is recommended

You are able to lead all aspects of execution of a clinical trial and you demonstrate expertise in vendor management.

You excel in organizing and motivating global or regional teams in a virtual environment.

You are a coach and a mentor.

Able to travel up to 20% of the time, (as defined by business need).

Relevant experience in the Late Development of a Therapeutic Area.

We are an equal opportunity employer and value diversity at our company. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

#GIFTS

What’s in it for you…?

“Caring for the world, one person at a time…”

As an employee we consider you as our most valuable asset. We take your career seriously.

As part of a global team in an innovative environment your development is key and our day-to-day responsibility.

Through e-university, on the job training, various projects and programs, we ensure your personal growth.

Our benefits make sure we care for you and your family now and in the future.